MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET BASIC TRAY (30 CM); PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number 4132105

Device Problem Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reaq1367 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that after insertion of the catheter, it became kinked while it was being removed from the patient.No harm to the patient was reported.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a catheter kink was confirmed and the cause appeared to be use related.The product returned for evaluation was a 2fr perqcath catheter.The catheter was returned with what appeared to be a bd insyte iv catheter which was dressed and positioned against the perqcath strain relief.Additionally, the stylet t-lock assembly remained attached to the perqcath luer but the stylet had been pulled through the t-lock septum and was not returned.Gross visual evaluation of the catheter revealed a kink in the bd insyte iv catheter at the luer hub of that device and this iv catheter kink would have also affected the underlying perqcath catheter.Following removal of the iv catheter, no permanent kink impressions could be seen on the bard perqcath device.Since the non-bard iv catheter kink affected the bard perqcath device the complaint was confirmed and it is possible that the combination use of both an iv catheter and perqcath catheter contributed to the kinking described in the event description.The simultaneous use of both an iv catheter and bard perqcath device is considered off-label use of the device.A lot history review (lhr) of reaq1367 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that after inserting the catheter in the patient, the catheter became kinked while it was being removed from the patient.No harm to the patient was reported.

• Brand Name: PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET BASIC TRAY (30 CM)
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: shauna nielson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225536
• MDR Report Key: 7038885
• MDR Text Key: 93201959
• Report Number: 3006260740-2017-02049
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741074837
• UDI-Public: (01)00801741074837
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K954104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4132105
• Device Catalogue Number: 4132105
• Device Lot Number: REAQ1367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1